A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

Conditions

• Adult Subjects With Allergic Diseases
• Atopic Healthy Subjects

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Accepted

Interventions

• YH35324 — DRUG
  Subcutaneous injection of YH35324
• Placebo — DRUG
  Subcutaneous injection of None of active ingredient
• Omalizumab — DRUG
  Subcutaneous injection of Omalizumab

Study Details

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

Key Dates

Start date

Nov 1, 2022

Status verified

Dec 2024

Primary completion

Nov 28, 2024

Completion

Nov 28, 2024

Study Design

Enrollment

46 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: YH35324
  There will be 5 dose groups of YH35324, escalating from low to high doses in a stepwise manner: Cohort 1(A mg/kg) → Cohort 2(B mg/kg) → Cohorts 3(C mg/kg) and 4(C mg/kg) → Cohort 5(C mg/kg) YH35324 and placebo will be administered in a double-blinded manner.
• Placebo Comparator: Placebo
  There will be 5 dose groups of YH35324, escalating from low to high doses in a stepwise manner: Cohort 1(A mg/kg) → Cohort 2(B mg/kg) → Cohorts 3(C mg/kg) and 4(C mg/kg) → Cohort 5(C mg/kg) YH35324 and placebo will be administered in a double-blinded manner.
• Active Comparator: Omalizumab
  For Cohort 3, omalizumab 300 mg will be administered in an open-label manner.

Primary Outcome Measure

Occurrence and severity of adverse events (AEs) [ Time Frame: Occurrence and severity of adverse events will be observed for 141 days after administration in Cohorts 1 to 5 ]